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A Phase 3, Randomized, Double-blind, Active-Controlled Study to Evaluate the Efficacy and Safety of HDM1002 Tablets Compared With Dapagliflozin in Adults With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-07-24
800
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of HDM1002 tablets compared to dapagliflozin in adults with type 2 diabetes mellitus (T2DM) who are not adequately controlled with metformin. This phase 3, multi-center, randomized, double-blind, active-controlled study aims to assess the efficacy and safety of these treatments. Participants will be stratified based on their baseline glycated hemoglobin (HbA1c) levels to better understand treatment effects in different subgroups. The study involves a screening period up to 2 weeks, followed by a 4-week metformin run-in before randomization. About 800 participants will be randomized in equal groups to receive one of three doses of HDM1002 tablets (starting from 50 mg and escalating every 4 weeks to maintenance doses of 100 mg, 200 mg, or 400 mg) or dapagliflozin 10 mg daily for 52 weeks. After treatment, there will be a 4-week follow-up. The primary endpoint is the change in HbA1c at Week 40. Participants will have regular assessments during the study, including measures of blood sugar control (HbA1c, fasting plasma glucose), insulin function, body weight, lipid profiles, blood pressure, and diabetes treatment satisfaction. Safety will be monitored through adverse event tracking, laboratory tests, physical exams, and vital signs throughout the 56 weeks of the study. Participants are expected to maintain consistent diet and exercise habits during the trial.
CONDITIONS
Brief Title
A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years inclusive
- Diagnosed with type 2 diabetes mellitus for at least 3 months
- Treated with a stable dose of metformin (at least 1500 mg/day or maximally tolerated dose not less than 1000 mg) for at least 8 weeks prior to screening and stable for 12 weeks before randomization
- HbA1c between 7.5% and 11.0% at screening and prior to randomization
- Body mass index (BMI) between 19.0 and 40.0 kg/m2 inclusive
- Female participants of childbearing potential and male participants agree to use highly effective contraception from consent until 30 days (female) or 90 days (male) after final dose
- Able to understand and comply with protocol, maintain diet and exercise habits, and provide informed consent
You will not qualify if you...
- Diagnosed with type 1 diabetes, special types of diabetes, or gestational diabetes
- Acute diabetes complications within 6 months before consent, such as ketoacidosis or coma
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type II
- History of pancreatitis or pancreatic injury, or symptomatic gallbladder disease needing treatment during trial
- Conditions affecting gastric emptying or nutrient absorption, including prior surgery or gastrointestinal disorders
- Cardiovascular events or severe heart conditions within 3 months prior to screening, including unstable angina, heart failure (class III or IV), myocardial infarction, or severe arrhythmias
- Proliferative diabetic retinopathy or maculopathy requiring treatment
- Known liver disease including active hepatitis B or C, or primary biliary cholangitis
- Recent or current use of certain drugs affecting metabolism that cannot be discontinued
- Use of glucose-lowering medications other than metformin within 4 weeks before consent
- Use of GLP-1 analogues within 3 months before consent or prior discontinuation due to safety or lack of efficacy
- Pregnancy or lactation
- Known hypersensitivity to SGLT-2 inhibitors or GLP-1 receptor agonists
- Participation in other clinical studies within 3 months prior to consent
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants continue metformin treatment as a run-in period to ensure stability before randomization.
Visits as per protocol during run-in period
Duration - 52 weeks
Participants receive randomized treatment with HDM1002 tablets or dapagliflozin once daily with dose escalation every 4 weeks until target dose is reached.
Regular visits throughout treatment for dose escalation and monitoring
Duration - Approximately 4 weeks
Participants are followed for safety and outcomes after the treatment period ends.
Visits to assess safety and final outcomes
Trial Site Locations
Total: 1 location
1
Yueyang People's Hospital
Yueyang, Hunan, China, 414000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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